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Results of Clinical and Patient-Reported Outcomes Data for Baricitinib in Patients with Rheumatoid Arthritis to be Presented at Annual European Congress of Rheumatology (EULAR 2016)

Lilly immunology portfolio to be featured in 16 presentations

INDIANAPOLIS, June 7, 2016 /CNW/ -- Eli Lilly and Company (NYSE: LLY) announced that radiographic results from a long-term extension study of baricitinib, RA-BEYOND, and patient-reported outcomes data from baricitinib's phase 3 global studies will be presented, along with other phase 2b and preclinical studies, at the Annual European Congress of Rheumatology (EULAR 2016) in London, June 8-11, 2016.

"We look forward to presenting new data from our immunology portfolio at the Annual European Congress of Rheumatology (EULAR 2016)," said J. Anthony Ware, M.D., senior vice president, product development, Lilly Bio-Medicines. "Lilly is committed to developing the next generation of treatments, especially for people with rheumatoid arthritis and psoriatic arthritis because these patients deserve new alternative treatment options."

Patient-Reported Outcomes from a Phase 3 Study of Baricitinib in Patients with Early Rheumatoid Arthritis who had Received Limited or no Treatment with Disease-Modifying Anti-Rheumatic Drugs (Presenting Author: Schiff, M.) Abstract Number: THU0623

About BaricitinibBaricitinib is a once-daily oral highly selective JAK1 and JAK2 inhibitor currently in late-stage clinical studies for inflammatory and autoimmune diseases. There are four known JAK enzymes: JAK1, JAK2, JAK3 and TYK2. JAK-dependent cytokines have been implicated in the pathogenesis of a number of inflammatory and autoimmune diseases, suggesting that JAK inhibitors may be useful for the treatment of a broad range of inflammatory conditions. Baricitinib demonstrates approximately 100-fold greater potency of inhibition against JAK1 and JAK2 than JAK3 in kinase assays.

In December 2009, Lilly and Incyte announced an exclusive worldwide license and collaboration agreement for the development and commercialization of baricitinib and certain follow-on compounds for patients with inflammatory and autoimmune diseases. Baricitinib was submitted for regulatory review seeking marketing approval for the treatment of rheumatoid arthritis in the U.S., European Union and Japan in Q1 2016, and is being studied in phase 2 trials for atopic dermatitis and systemic lupus erythematosus.

About Rheumatoid ArthritisRheumatoid arthritis is an autoimmune disease characterized by inflammation and progressive destruction of joints.[i,ii] More than 23 million people worldwide suffer from RA.[iii] Approximately three times as many women as men have the disease. Current treatment of RA includes the use of non-steroidal anti-inflammatory drugs, oral conventional disease-modifying antirheumatic drugs (cDMARDs), such as methotrexate – the current standard of care – and injectable, biological disease-modifying antirheumatic drugs (bDMARDs) that target selected mediators implicated in the pathogenesis of RA.[iv] Despite current treatment options, many patients do not reach their therapeutic goals or sustained remission.[v,vi] There remains an important need to provide additional treatments to improve overall patient care.

About IxekizumabIxekizumab is a humanised IgG4 monoclonal antibody that selectively binds with interleukin 17A (IL-17A) cytokine and inhibits its interaction with the IL-17 receptor. [vii] IL-17A is a naturally occuring cytokine that is involved in normal inflammatory and immune responses. [vii] Ixekizumab inhibits the release of pro-inflammatory cytokines and chemokines.[ix] Ixekizumab is in clinical development for the treatment of psoriatic arthritis and axial spondlyoarthritis.

About Psoriatic ArthritisPsoriatic arthritis is a chronic, progressive form of inflammatory arthritis that can cause swelling, stiffness and pain in and around the joints, nail changes and impaired physical function. If left untreated, psoriatic arthritis can cause permanent joint damage. Up to 30 percent of people with psoriasis also develop psoriatic arthritis.[x]

About Eli Lilly and CompanyLilly is a global healthcare leader that unites caring with discovery to make life better for people around the world. We were founded more than a century ago by a man committed to creating high-quality medicines that meet real needs, and today we remain true to that mission in all our work. Across the globe, Lilly employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to communities through philanthropy and volunteerism. To learn more about Lilly, please visit us at www.lilly.com and newsroom.lilly.com/social-channels.

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This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about baricitinibas a treatment for rheumatoid arthritis and ixekizumabas a treatment for psoriatic arthritis, and reflects Lilly's current beliefs. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of development and commercialization. Among other things, there can be no guarantee that future study results will be consistent with study findings to-date, or that baricitinib or ixekizumab will receive regulatory approvals or prove to be commercially successful. For further discussion of these and other risks and uncertainties, see Lilly's most recent 10-K and 10-Q filings with the United States Securities and Exchange Commission. Except as may be required by law, Lilly undertakes no duty to update forward-looking statements for events occurring after the date of this release.